Pharmacy Prior Authorization Criteria

Crenessity (crinecerfont)

For diagnosis of Congenital Adrenal Hyperplasia (CAH)
Indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Congenital Adrenal Hyperplasia (CAH)

AND

AND

Patient is receiving chronic treatment with glucocorticoid (GC) replacement therapy (e.g., dexamethasone, hydrocortisone, methylprednisolone) for adrenal insufficiency as one of the following:

Patient is 4 to 17 years old
Daily GC dose is greater than 12 mg/m2/day in hydrocortisone dose equivalents [B]

Patient is 18 years of age or older
Daily GC dose is greater than 13 mg/m2/day in hydrocortisone dose equivalents [C]

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Congenital Adrenal Hyperplasia (CAH)

Patient demonstrates positive clinical response to therapy (e.g., lowered androgen levels, reduced daily dose of steroids)

AND

Patient continues to receive chronic treatment with glucocorticoid (GC) replacement therapy (e.g., dexamethasone, hydrocortisone, methylprednisolone)

AND

2026-01-05, 2025-07-09, 2025-02-06

Crenessity Prescribing Information. Neurocrine Biosciences, Inc., San Diego, CA. December 2024.
Speiser PW, Arlt W, Auchus RJ, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018; 103(11):4043-4088.
Sarafoglou K, Kim MS, Lodish M, et al.; CAHtalyst Pediatric Trial Investigators. Phase 3 trial of crinecerfont in pediatric congenital adrenal hyperplasia. N Engl J Med. 2024; 391(6):493-503.
Auchus RJ, Hamidi O, Pivonello R, et al.; CAHtalyst Adult Trial Investigators. Phase 3 trial of crinecerfont in adult congenital adrenal hyperplasia. N Engl J Med. 2024; 391(6):504-514.

Clinical practice guidelines recommend therapy monitoring and evaluation every 4 months in pediatric patients older than 18 months and at least annually in adult patients. It should be noted that the guideline has not been updated to incorporate monitoring recommendations on crinecerfont therapy. The double-blind investigational durations of the pivotal trials were 24 weeks for the CAHtalyst adult study and 28 weeks for the CAHtalyst pediatric study. [2-4]
Corticosteroid dosages as maintenance treatment in growing patients are hydrocortisone 10 to 15 mg/m2/day or fludrocortisone 0.05 to 0.2 mg/day. In the pivotal trial for children, the dose equivalent of prednisone or prednisolone to hydrocortisone 12 mg is 3 mg (1 mg prednisone/prednisolone equivalent to 4 mg hydrocortisone). [2, 3]
Total daily dosages of corticosteroids as maintenance therapy for adults are hydrocortisone 15 to 25 mg, prednisone 5 to 7.5 mg, prednisolone or methylprednisolone 4 to 6 mg, dexamethasone 0.25 to 0.5 mg, or fludrocortisone 0.05 to 0.2 mg. In the pivotal trial for adults, the equivalency factor of hydrocortisone 13 mg is 4 times for methylprednisolone, prednisolone, and prednisone, and 60 times for dexamethasone. [2, 4]